Senior Design Quality Engineer

Health Innovation Research Alliance Northern Ireland; Belfast; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading company in medical devices is hiring a Senior Design Quality Engineer in Belfast. The role involves ensuring the highest quality in product design, managing risk assessments, and leading quality initiatives. Candidates should have a strong background in engineering, significant experience in regulated environments, and knowledge of medical device industry regulations and practices.

Qualifications

• 2+ years of experience in a highly regulated environment.
• Strong knowledge of medical device industry policies and regulations.
• Prior experience with electro-mechanical commodities and embedded software.

Responsibilities

• Lead product safety risk management activities including hazard analysis and risk assessments.
• Establish field performance trending metrics to identify improvement opportunities.
• Participate in internal & external audits with regulatory representatives.

Skills

Quality tools for process capability

Root cause investigation

Test method validation

Education

Bachelor's Degree in Engineering

Job description

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Stryker is hiring a Senior Design Quality Engineer in Belfast, to support our Medical Business. You will work as the Design Quality Engineering partner within a cross-functional product development team to enable timely launch of the highest quality products that meets and exceeds customer and stakeholder expectations in support of a successful product lifecycle of a medical device. You will serve as a representative for the Quality Management System at all times and drive continuous process improvement.

What you will do:

Participate in the product development process by ensuring that all the quality data streams are fully comprehended and that the voice of the customer, as heard through these data streams (complaints, non-conforming records, verified failures, etc.), is a design input and consideration.

Lead product safety Risk Management activities, including, characterization and estimation of design risks, which includes both the appropriate control activities and proper identification in downstream design outputs. Develop Risk Management File deliverables including Product Hazard Analysis, design failure modes and effects analysis [DFMEA], Critical to Quality characteristics on specifications, Risk Assessments for issues impacting distributed product, etc.

Develop validation strategies for projects that are consistent with design validation policies and procedures. Provide technical direction and approval of validation plans, protocols, reports.

Provide technical direction in optimization of test plans, test methods and sampling.

Advocate and lead the execution of initiatives & projects to improve Quality throughout the organization

Establish appropriate field performance trending metrics using standardized reporting mechanisms, analyze results to identify emerging trends and improvement opportunities, and reporting for production and post-production monitoring of new products after launch.

Provide Quality leadership to drive the timely resolution of quality issues impacting assigned product lines and participate in the CAPA process as task owner/contributor as appropriate and necessary. Advise on risk management investigations for HHE, PFAs, NCs and CAPAs or other post-market issues as needed.

Participate in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of product development within the Design Controls process.

As a Senior level engineer, seek out learning opportunities across Stryker to advance technical skills and knowledge and develop subject matter expertise

What you will need:

Bachelors Degree in Engineering (biomedical engineering preferred)

2+ years of experience working in a highly regulated environment, quality, manufacturing, or engineering.

Strong knowledge of medical device industry policies and regulations.

Prior experience working with electro-mechanical commodities and embedded software in a product development capacity

Knowledge of quality tools for process capability, root cause investigation, developing sampling plans, test method validation, or other Quality tasks

Knowledge of good design practices, specification development, industry standards, etc.